Mode
Text Size
Log in / Sign up
N/A N=31 Randomized Double-blind Prevention

Nasal Bridles and Repeat Endoscopic Procedures for Endoscopic Nasoenteric Tubes

Feeding Disorders

Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Repeat Endoscopy to Replace Dislodged Feeding Tube — 3; 2 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Nasal Bridle (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
St. Louis University
Primary completion
Mar 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Repeat Endoscopy to Replace Dislodged Feeding Tube
3; 2
SECONDARY
Inadvertent Tube Dislodgement
7; 2

Summary

In critically ill patients, nutrition is a major part of healing and recovery. In patients unable to tolerate oral feeding, nasoenteric tube feeding (a tube placed from the nose to the stomach or small intestine) provides a safe alternative for feeding. Some patients require these tubes to be placed endoscopically due to numerous patient factors including difficult anatomy, need for post-gastric feeding, among others). In patients that require endoscopically placed tubes, there is risk of perforation, infection, bleeding, aspiration, and rarely even death. In patients that have recurrent dislodgement of endoscopically placed tubes, the need for repeat endoscopy increases patient exposure to these risks. Traditional securing mechanism with adhesive tape to reduce dislodgment often fail in critically ill patients requiring patients to have repeat endoscopies to replace nasoenteric feeding tubes and subjects patients potentially to increased cumulative risks associated with each endoscopy. The investigators propose to collect data for one year, the investigators will prospectively follow via chart review endoscopically placed naso-enteric tubes placed with a Standard AMT Bridle securement device and assess if there is a reduction in accidental tube removal requiring replacement endoscopically.

Eligibility Criteria

Inclusion Criteria

  • Patients in need for endoscopically placed nasoenteric feeding tube

Exclusion Criteria

  • Age greater than 90 years
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03966157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search